Gliederung

Introduction: A decision of the Federal Joint Committee Germany stated that negative pressure wound therapy (NPWT) is not accepted as a standard therapy with full reimbursement by health insurance companies in Germany. The German government stated that further research of high quality is necessary in order to provide sufficient evidence for the clinical benefit of NPWT. Thus, the DiaFu-study was initiated with the aim to compare the effects of negative pressure wound therapy (NPWT) and standard wound care in both medical sectors (in and outpatient care) [1], [2].

Methods: Within a European tender the study was initiated by the statutory health insurance in Germany and has been performed between 2012 and 2015. During this time 345 patients were randomised.

The Institute for Research in Operative Medicine (IFOM) of the University of Witten/Herdecke was responsible for the scientific conception, analysis and reporting of the study. Furthermore, IFOM monitors the compliance with regulatory and quality requirements. A management company, Gesundheitsforen Leipzig (GFL), was responsible for the logistics, the financial aspects and the study site selection, as well as patient recruitment. The study database was provided and hosted by the GFL. The manufacturers Kinetic Concepts Incorporated (KCI) and Smith & Nephew (S&N) provided the NPWT systems as well as all necessary information about the used medical devices.

Responsibilities and tasks for the data management were devided between the management company and IFOM. The GFL was responsible for the ordering and accounting system for the NPWT devices as well as the implementation and deployment of the data management program (OpenClinica), respectively the electronic CRF (eCRF). Data exchange for tracking, wound photos etc. happened in a batch mode because of the high amount of data to be treated. The study sites have been asked to provide information regarding their experiences satisfaction with the data management solution and the trial itself.

Results: The investigators used the implemented software for ordering, randomization, clinical data und wound photo upload. The survey covered 61 centers and contained 45 questions in five categories like study preparation, execution, and assistance. It exhibited that some improvement was desired concerning the comprehensibility, usability and response time. The internal data processing was split between partners, interfaces helped to use and analyze the data. Nevertheless due to the initial design some work was necessary in order to interface data. A further crucial aspect is the split between supervising data management and the data management itself combined with the necessity to process data in a batch mode. Also, splitting data management and monitoring caused fictional losses. Different databases at different places had to be joined using additional software tools.

Discussion: In a study setup with several partners the definition of tasks and interfaces can be crucial. In order to avoid additional programming work a tender should take care of software specific requirements. An integrated software tool that helps to guide the investigators and collect heterogenic data is very helpful. By these means investigators can be supported to run a study more smoothly.